MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

Device Problems Premature Discharge of Battery (1057); Energy Output To Patient Tissue Incorrect (1209)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2016

Event Type  malfunction  

Event Description

During analysis of a returned generator, it was identified that the device experienced fluctuations in the voltage output during system diagnostic tests.An atypical output waveform occurred when the generator was programmed off, sensing was enabled and a system diagnostic test was performed.The generator can was opened and the printed circuit board assembly failed multiple electrical tests.The supply current drain with sensing enabled was outside of specification, but met specifications when sensing was off.The a2 asic was replaced and the generator then passed all functional specifications.The malfunctioning a2 asic was sent to the vendor for analysis.The asic was returned and the vendor verified the output variation through internal testing.The vendor inspected the units under a microscope and via x-ray imaging and found no visual anomalies.None of the tests performed identified the cause of the amplitude fluctuations.

Manufacturer Narrative

(b)(6) 2017.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6640329
• MDR Text Key: 77543587
• Report Number: 1644487-2017-03978
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/08/2017
• Device Model Number: 106
• Device Lot Number: 04573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 17 YR